NCT06890013

Brief Summary

A prospective, single-center, observational study aiming to assess the predictive role of flow mediated dilatation in acute coronary syndromes, combined with echocardiographic and biochemical indices. The novel Cor-IS technology will also be evaluated.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jun 2024Nov 2026

Study Start

First participant enrolled

June 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

March 17, 2025

Last Update Submit

February 27, 2026

Conditions

Endothelial Function (FMD)Acute Coronary SyndromesFlow Mediated Dilation

Keywords

acute coronary syndromeendothelial dysfunctionbiomarkerflow mediated dilatation

Outcome Measures

Primary Outcomes (1)

  • Brachial artery endothelial function assessment using the Cor-IS method compared to FMD

    The primary outcome of the study is the assessment of brachial artery endothelial function in the therapeutic approach using the Cor-IS method compared to the reference method FMD. The indices of the FMD method (FMD%, shear rate, and FMD/shear) will be compared with the R index of the Cor-IS method at the study's baseline and during follow-up.

    12 months

Secondary Outcomes (8)

  • FMD% index and MACE

    12 months

  • R-index and MACE

    12 months

  • FMD% index and rehospitalizations for angina

    12 months

  • R-index and rehospitalizations for angina

    12 months

  • FMD% index and need for revascularization

    12 months

  • +3 more secondary outcomes

Study Arms (1)

Observation group

Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI)

Diagnostic Test: Observation group

Interventions

Observation groupDIAGNOSTIC_TEST

Patients with acute coronary syndrome undergo endothelial function assessment using two methods (flow mediated dilatation of the brachial artery and Cor-Is technology) transthoracic echocardiogram and plasma biomarkers' measurement.

Observation group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI) are considered eligible for the study.

You may qualify if:

  • Age \> 18 years
  • Patients hospitalized due to acute coronary syndrome (STEMI, NSTEMI)
  • Capability of providing written informed consent
  • Patients able to comply with the follow-up schedule of the study

You may not qualify if:

  • Patients with acute coronary syndromes classified as MINOCA, or type II myocardial infarction
  • Patients with rare acute coronary syndrome types, such as spontaneous coronary artery dissection or Takotsubo syndrome
  • Patients with congenital heart disease
  • Age \> 85 years
  • Patients with end stage chronic kidney disease
  • Patients with active malignancy or autoimmune diseases which limit their survival
  • Patients with expected survival \< 1 year due to other reasons
  • Suboptimal echocardiographic windows
  • Inability to provide written consent
  • Inability to comply with the follow-up schedule of the study
  • Pregnancy
  • Use of intravenous drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ippokratio General Hospital

Thessaloniki, 54642, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

40 ml plasma specimen (-80 grades Celsius)

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Christodoulos E. Papadopoulos, PhD

    Aristotle University of Thessaloniki, Greece

    PRINCIPAL INVESTIGATOR

  • Georgios Zormpas, MD

    Aristotle University of Thessaloniki, Greece

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christodoulos E. Papadopoulos, PhD

CONTACT

2313312343chrpapado@gmail.com

Georgios Zormpas, MD

CONTACT

2313312343sparky.zorb@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 21, 2025

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

GR(1)